CLINICAL EXPERIENCE AND USE OF SABRIL IN PATIENTS WITH PARTIAL SEIZURES

SABRIL 在部分性癫痫发作患者中的临床经验和使用

• 批准号: 6277013
• 负责人: KATHERINE HENRY
• 金额: $ 2.03万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-12-01 至 1998-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6277013
• 关键词: anticonvulsants; clinical research; clinical trials; drug adverse effect; human subject; human therapy evaluation; nervous system disorder chemotherapy; partial seizure

The goal of this multicenter, open-label, flexible-dose, long-term study is to further evaluate the safety and efficacy associated with the use of Sabril in epilepsy patients having partial seizures, and whose lifestyle has been adversely affected by poor seizure control and/or adverse events from currently marketed anti-epilepsy drugs (AEDs). Sabril (500 mg tablets) will be supplied in open-label bottles. The dosage will be titrated up to a maintenance dose of 2 to 3 g/day. The maximum allowable dose for the study is 6 g/day, as determined by the investigator dependent on patient response. Efficacy will be measured by the patient's response to Sabril with regard to seizure control, seizure frequency and seizure type. In addition, patient responses to selected quality-of-life questions will be measured with the QOLIE-10 (Quality of Life in Epilepsy) instrument, and patient and physician global assessment of drug therapy will be evaluated. Safety parameters will be assessed through collection of adverse events and monitoring laboratory values.

这项多中心、开放标签、灵活剂量、长期研究的目的是 是为了进一步评估与使用 在部分性癫痫发作的癫痫患者中， 生活方式受到癫痫控制不良的不利影响和/或 目前上市的抗癫痫药物（AED）的不良事件。 Sabril（500 mg片剂）将以开放标签瓶装供应。的 将剂量滴定至2 - 3 g/天的维持剂量。 的 研究的最大允许剂量为6 g/天，由 研究者依赖于患者的反应。 将测量疗效 通过患者对Sabril在癫痫控制方面的反应， 发作频率和发作类型。 此外，患者对 将使用QOLIE-10测量选定的生活质量问题 （癫痫生活质量）仪器，患者和医生 将对药物治疗的总体评估进行评价。安全性参数 将通过收集不良事件和监测进行评估 实验室值。